Digoxin

Product NDC: 0615-8202
11-digit product format: 006158202
Labeler code: 0615
Product ID: 0615-8202_7d86bdf3-c349-4ba6-9820-e6f8b61b78e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA077002
Marketing category: ANDA
Marketing start: 2007-10-30
Marketing end: 0000-00-00
Substance: DIGOXIN
Active strength: 125 ug/1
Pharmacologic classes: Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-8202-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-8202-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-8202-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-8202-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-8202-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-8202-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-8202-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-8202-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-8202-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-8202-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-8202-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-8202-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-8202-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-8202-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-8202-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-8202-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-8202-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-8202-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-8202-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-8202-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-8202-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-8202-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-8202-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-8202-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077002-001	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB		2007-10-30
A077002-002	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB		2007-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077002-001	AB
A077002-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077002-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077002-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077002-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077002-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077002-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077002-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077002-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077002-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077002-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077002-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077002-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077002-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077002-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077002-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077002-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077002-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077002-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077002-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Digoxin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIGOXIN	125 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
73K4184T59	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197604	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5886e233-b2da-4acb-be05-9bf40fb8e7f4	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	NCS HealthCare of KY, LLC dba Vangard Labs	5886e233-b2da-4acb-be05-9bf40fb8e7f4	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002 ndc (product): 0615-8202
Digoxin	DIGOXIN	Golden State Medical Supply, Inc.	2636527a-1ecd-455f-a928-19549ac83fa1	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002
Digoxin	DIGOXIN	Cardinal Health 107, LLC	51925501-ab5b-4e12-a67e-ec2b4b592e83	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002
Digoxin	DIGOXIN	Major Pharmaceuticals	48cad559-c17b-4d41-a154-e664e958c1c0	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	41c16cff-b03e-405e-a617-d6f45d3ce2bd	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
73K4184T59	DIGOXIN	20830-75-5	DIGOXIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8202-05	00615820205	15 TABLET in 1 BLISTER PACK (0615-8202-05)	15 tablet	2022-06-06	0000-00-00	No	No	Current
0615-8202-30	00615820230	6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8202-30) > 5 TABLET in 1 BLISTER PACK	6 blister pack	2008-02-28	0000-00-00	No	No	Current
0615-8202-39	00615820239	30 TABLET in 1 BLISTER PACK (0615-8202-39)	30 tablet	2007-10-30	0000-00-00	No	No	Current